Medical Writing Services for Medical Devices and In Vitro Diagnostics (IVDs)

LFH Regulatory understands the significance of medical writing and we are dedicated to offering tailored services that align with the distinct needs of both Medical Device and In Vitro Diagnostic Device (IVD) manufacturers. Our services also include conducting robust and effective Post Market Surveillance (PMS), ensuring your products continued compliance into the future.  

Medical Writing Services

At LFH Regulatory, our suite of medical writing services is designed to provide you with comprehensive support throughout your product’s lifecycle. Our team of seasoned medical writers are well-versed in crafting documents that meet stringent regulatory requirements, ensuring that your message is communicated effectively and compliantly. 

Our services include:

Regulatory Writing

We specialise in creating regulatory documents such as Premarket Submissions, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and more. Our expert writers ensure that your regulatory documents adhere to the latest requirements for your market(s).

Scientific Communication

We transform complex scientific data into clear and accessible content. Whether it is manuscripts for publication, scientific presentations, or educational materials, we make sure your message is communicated effectively and is impactful.

Clinical Documentation

Our team is skilled in generating clinical trial protocols, investigator brochures, and patient information leaflets. We can help you navigate the rigorous documentation required for clinical studies.

Quality Control

Accuracy is paramount in medical writing. We employ rigorous quality control measures to ensure that your documents are error-free and compliant to your applicable regulations and standards.

Customisation

We understand that every project is unique. Our services are customised to meet your unique needs, delivering documents that cater to your specific requirements.

Medical Device Clinical Evaluations

Clinical Evaluation is a critical ongoing component to collect, assess and analyse your clinical data to verify the safety and performance for its intended use. At LFH Regulatory, we specialise in compiling Clinical Evaluation Reports (CERs) that not only meet applicable regulatory standards but also demonstrate that there is sufficient clinical evidence to verify the safety and performance of your device. 

Our CER services include:

Comprehensive Data Analysis

We deep dive into your clinical data, analysing it thoroughly to uncover insights that support the safety and efficacy of your device.

Regulatory Compliance

Clinical Evaluation Reports (CERs) play a pivotal role in the regulatory submission process for medical devices. At LFH Regulatory, we specialise in crafting comprehensive CERs that adhere to stringent regulatory standards. Our expertise ensures that your CERs effectively demonstrate the safety and performance of your medical devices.

Clinical Evaluation Documentation Writing

We can write all the documents required for a clinical evaluation including clinical evaluation plan, identify and appraise pertinent data, creation of Post Market clinical Follow-up (PMCF).

Clinical Investigations

Clinical Investigations for Medical Devices   

Clinical Investigation is a pivotal step in demonstrating the safety and effectiveness of medical devices. LFH Regulatory’s experts are skilled in planning, executing, and reporting on these investigations. 

We have helped clients during the following stages of the investigation process:  

  • Investigator’s Brochure
  • Clinical Investigation Plan 
  • Ethical Approval  
  • Clinical and non-clinical overviews 
  • Clinical expert statements 
  • Briefing documents 
  • NDAs 
  • Labelling

 

Our clinical performance investigation services include:

Study Design

We work with you to design clinical studies that are scientifically rigorous and aligned with regulatory expectations.

Study Management

Our team manages every aspect of your clinical studies, from site selection and patient recruitment to data analysis and reporting.

Regulatory Compliance

We ensure that your clinical investigation meets all regulatory requirements, supporting your device's approval and market access.

In Vitro Diagnostic Device Performance Evaluations (PER)

Performance Evaluation is required for any In Vitro Diagnostic (IVD) where you want to place your product on the EU market. Performance Evaluation Reports (PERs) are instrumental in highlighting your clinical evidence including your scientific validity, analytical and clinical performance data. LFH Regulatory excels in creating PERs that are comprehensive, compliant, and compelling. 

Our PER service covers:

  • Data Collection: We collate and analyse all relevant data, presenting a comprehensive overview of your IVD’s performance. 
  • Compliance Assurance: Our experts ensure that your PERs align with the latest regulatory standards, facilitating market access and compliance. 
  • Documentation Review: We can also conduct documentation reviews for any type of document and these often consist of reviewing against specific standards, compliance against the regulation and other checks that ensure the quality of your documentation meet the targeted standards.
  • Literature Review: Our experts will conduct a review of peer-reviewed literature papers to substantiate product claims, safety and performance which enables the validity of your products to stand up to any potential scrutiny before going to market.
  • Gap Analysis: The team at LFH can conduct a gap analysis of your current documentation and identify deficiencies in your documentation to ensure your products compliance with targeted regulations.
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Performance Testing for IVDs

Performance testing is a crucial step in ensuring the quality and reliability of IVDs. LFH Regulatory can you assist you with the allocation of this testing. While we do not directly test devices ourselves, our extensive experience in the field equips us to guide you through this process and sure you document it correctly.  

Our Performance Testing services include helping you allocate the following steps of your performance testing. 

Method Development

We assist you in developing robust analytical methods tailored to your device's specifications.

Precision and Accuracy Assessment

Our experts assist you with allocating the resources that enable your company to conduct thorough testing to evaluate the precision and accuracy of your device, ensuring it meets the highest standards.

Regulatory Documentation

We help you create the necessary documentation to demonstrate compliance with applicable regulatory requirements.

Tailored Services for Medical Devices and IVDs

LFH Regulatory recognises the complex needs of medical device and IVD manufacturers. Our medical writing services are meticulously tailored to address the specific requirements of each category, ensuring that you receive documents that are not only accurate and compliant but also strategically positioned to support your market goals. 

LFH Regulatory is your trusted partner for comprehensive and bespoke medical writing services. Our expertise, attention to detail, and commitment to regulatory compliance make us the preferred choice for manufacturers seeking top-tier medical writing support. For personalised assistance with your medical writing needs, please don’t hesitate to contact us.